Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)

Immune Thrombocytopenic Purpura Clinical Trial

Official title:

Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510873
• Other study ID #: QoL-ITP0411
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 22, 2014
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising, menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of pITP patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed with pITP. The investigators project will aim at providing scientific community solid evidence based data on the extent to which HRQOL is compromised and in which specific area.

The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL) profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of a matched Italian population control Group.

Description:

OBJECTIVES:

The primary objective is to compare HRQOL of patients with pITP with that of a matched Italian population control Group.

Secondary objectives include evaluation of:

• Patient-reported fatigue amongst the three different pITP groups.

• Social support and psychological wellbeing as a possible determinant of HRQOL.

• Possible association between socio-demographic (e.g., age, living arrangements, education and employment status) and clinical variables (e.g., time from diagnosis, and current treatment if any) with patient reported health outcomes (e.g., HRQOL, fatigue, and social support).

• To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics and to compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians (only for Newly Diagnosed pITP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A confirmed diagnosis of pITP in any phase of the disease;

• Patients aged at least 18 years;

• Informed consent provided

Exclusion Criteria:

• Participating in other HRQOL investigations that might interfere with this study

• Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.

Related Conditions & MeSH terms

• Fatigue
• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Other:
• HRQOL evaluation
Patients will be asked to complete a Questionnaire (i.e. HRQOL Survey Packet) that will cover a number of issues. These will include socio-demographic aspects, HRQOL information, symptom burden, clinical decision-making, social support and psychological wellbeing. Most of these information will be collected through well known psychometrically sound questionnaires. The copyright for using standardized questionnaires will be obtained, from the appropriate copyright holders, for the purpose of this research. The Questionnaire properly formatted will be distributed to all participating Centers prior to study start.

Locations

Country	Name	City	State
Italy	Ospedale Generale Regionale "F. Miulli"	Acquaviva delle Fonti
Italy	Azienda Ospedaliero-Universitaria Policlinico Consorziale	Bari
Italy	Azienda Sanitaria Locale BA - Ospedale di Venere	Bari
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Ospedale Binaghi	Cagliari
Italy	Ospedale Businco	Cagliari
Italy	U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche	Campobasso
Italy	US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo	Castelfranco Veneto
Italy	Azienda Ospedaliero Universitaria	Foggia
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	DIMI- Clinica Ematologica - Università degli studi di Genova	Genova
Italy	Ospedale Santa Maria Goretti	Latina
Italy	Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"	Messina
Italy	Azienda Ospedaliera Universitaria - Policlinico "G. Martino"	Messina
Italy	Azienda Ospedaliero - Universitaria di Modena	Modena
Italy	Azienda Ospedaliera "S. Gerardo dei Tintori"	Monza
Italy	S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro	Novara
Italy	Ospedale S. Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone	Palermo
Italy	Azienda Ospedaliero - Universitaria di Parma	Parma
Italy	Azienda Ospedaliera "Bianchi - Melacrino - Morelli"	Reggio Calabria
Italy	U.O.C. Ematologia - Ospedale S.Eugenio	Roma
Italy	U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita	Roma
Italy	UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"	Rome
Italy	Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Italy	U.O. Ematologia, Azienda Ospedaliera Universitaria Senese	Siena
Italy	Azienda Ospedaliero - Universitaria "San Giovanni Battista"	Torino
Italy	Azienda Ospedaliera	Treviglio
Italy	ULSS N.6 Ospedale San Bortolo	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.		By the end of the study.
Secondary	Patient-reported fatigue amongst the three different pITP groups		By the end of the study.
Secondary	Patient-reported fatigue amongst the three different pITP groups.		By the end of the study.
Secondary	Possible association between socio-demographic and clinical variables with patient reported health outcomes.		By the end of the study.
Secondary	To assess patients' preferences for involvement in treatment decision-making.		By the end of the study.

External Links

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